Afternoon, everyone. Welcome to the Jefferies Healthcare Conference. My name is Anthea Li, part of the healthcare research team here at Jefferies. Today, we are very fortunate to have Esperion with us and CEO Sheldon Koenig with us. Thanks for being here, Sheldon.
Thank you. Appreciate it. Thank you.
For those who are kind of newer to the story, could you just talk a little bit about bempedoic acid, and especially in the last year or so, what we term Launch 2.0, and frame that kind of opportunity for us?
Yeah. First of all, thank you again. Really appreciate Jefferies having us at this meeting. It's been a really good meeting for us. We've met with many folks today. The history of Esperion has really been a turnaround story. It's something that started even as late as 2021, where we were really focusing on several different factors. Some of them were related to controlling our burn rate, growth, focusing on the CLEAR Outcomes Study, completing that study, and getting a label. To fast forward, I think, as everyone knows, back in 2023, we presented the CLEAR Outcomes Data, 14,000 patient outcome study. April of last year, we received our new label. Even going back to 2021, we showed high single-digit growth. Then once we had our label, high double-digit growth. Why is that?
The label was something that allowed us to expand our market. We went from a TAM of 10 million patients to 70 million patients. We received not only a secondary prevention indication, but we also received a primary prevention indication. We are the only non-statin on the market to actually have an indication in primary prevention. The new label has really fueled our opportunity and our growth. We always talk about the fact that this drug has an opportunity to have peak sales of greater than $1 billion. We stand by that. I think later you are going to ask me some questions around IP, et cetera. We will talk about how it could even be even more. We are really happy with our growth. We are really seeing an acceleration in this quarter of our growth as well. That is what we hope to continue to show.
Talk a little bit about coverage and how that has changed given the primary care label update. Are you also seeing more primary care docs getting on? What is the share of kind of prescriptions between primary and secondary right now that you're seeing?
Yeah. Our representatives, for the most part, call on both primary care physicians and cardiologists. About 1% is endocrinologists as well. What we've seen with the primary prevention data, this is a story that really resonates with primary care physicians. We've seen primary care physicians continue to accelerate their adoption of the drug. It's quite interesting that a drug that was essentially launched five years ago, but to your point, Launch 2.0 with the new label, we are seeing continued new writers. These are people that have never written the drug before. We're seeing that a lot of that is based upon primary care physicians using the drug, thinking about primary prevention. What we're also seeing is something we're emphasizing is statin intolerance.
This acceleration of the growth that we've been seeing, we've been going to physicians who've never used a drug before and talking to them about the fact that they can use this drug for patients who cannot take a statin. You may recall the NLA back in February issued a statement that said up to 30% of patients who need LDL lowering cannot take a statin. We know these patients sit in everybody's office waiting. Physicians, after hearing this message, have found it compelling, especially primary care, and using it there. From a coverage perspective, we have 92% coverage in commercial. We have 72% coverage in Medicare, all preferred, over 193 million lives covered. I think the biggest change with the label is you used to have to jump through a lot of step edits, multiple use of statins. You had to get through ezetimibe.
That's gone. There's no multiple step edits through statins. As I said, if you can't take a statin, you can go right to Nexlizet. There's no step edit through ezetimibe. In some cases, we have plans, just to give you a quick two examples, Aetna, SilverScript, you don't even need a prior authorization. For a branded product these days, not needing a prior authorization, that's a really big deal. One last fact, we've added 15 field reimbursement managers. This is one person per region that's embedded that can help offices get the drug approved if they're having issues. We launched that on April 1st of this year. We've already seen an increase from about 72% to the 80% level in commercial. In Medicare, we've gone from 80% to an 86% approval.
We think it's because of these field reimbursement managers that were only launched in April that are helping us get there.
Great. Access is clearly improved. What about the perception of access? Is that still kind of a lingering barrier to uptake?
Where it is a lingering barrier, we are using these field reimbursement managers. There are some pockets. We know where that exists, and we're addressing it with essentially FRMs is the acronym. What we're finding is more and more physicians, and I think even with the upramp we've seen in the second quarter, are seeing that it's easier to get Nexlizet than it ever has been.
Okay. In terms of a revenue impact, you are already seeing these field reimbursement managers come into play and increase access and improve prescriptions. Is that fair?
Absolutely. No question about it.
Okay. Great. I also wanted to ask about kind of the call points that you have right now. Is it primarily focused on primary care physicians and growing that portion of the business, or is cardio still a focus? How does that make up the share of prescriptions?
Yeah. Cardiologists are always very important. If you think about the essentially cascade of influence, cardiologists are at the top. Picture a triangle. They're at the top on a regional basis. A lot of primary care physicians look to them for information. Right now, from a call deck perspective, if I was out in the field, about 50% of my call point, or actually a little less than 50%, would be on cardiologists. The remainder would be on primary care physicians. We're definitely seeing primary care physicians outpace the prescribing of cardiologists in most areas. I think just by the sheer number of primary care physicians that are out there, it's a function of that. Keep in mind, we have 155 representatives. We feel that we have found the right balance between personal promotion and nonpersonal promotion. What do I mean by that?
Personal promotion are the representatives. Nonpersonal promotions, we've been attacking via digital. For instance, in the EHR prescribing, a physician, when they're prescribing bempedoic acid or considering prescribing, they'll see a banner ad come across. We're also sending emails. The representatives have the ability to send what are called virtual prescribing emails to physicians as well. They've been doing that in the thousands. We actually have done a return on investment analysis. We actually see a seven to one return in that digital application. A question we always get is, do you need more people, et cetera? We've got the right amount of people. We've got the right nonpersonal promotion balance as well. We've been quite effective in getting the message out there to get the prescribing.
Got it. In terms of the cadence of revenues throughout 2025, obviously, Q1 was a little softer due to insurance issues, seasonality. You mentioned kind of field reimbursement managers kicking in this quarter. Should we expect an acceleration into the back half of the year?
Right now, based upon the trajectory that we see, we see growth returning to what we would say double digit. We're comfortable with the consensus that's out there on the street as it relates to us. I think growth will continue to accelerate. That's one thing about this market. It's such a large market. We've shown before that, and even in the first quarter, which was a tough quarter for everyone, we showed a 2% growth in the market that's flat. I would go as far to say that based upon the acceleration we've seen, the rebound from the first quarter, just looking forward, one of the questions we get is, when do we think we'll be profitable, et cetera? We think by the first quarter of 2026, the organization will be profitable. That's the first time we're out there saying that.
We actually think we'll have profitable quarters even before that because of the milestone payments that we'll be receiving from Otsuka, up to $130 million later into the fourth quarter. We are very pleased with what we're seeing as we go into the second half of the year and leading even into the first quarter of 2026 and beyond.
To be clear, that profitability in Q1 would be outside of those Otsuka milestones?
That is correct. Yes.
I think consensus has bempedoic acid doing $165-$170. That's the range that you feel you would be comfortable in hitting this year.
We're comfortable with the range that we see right now. Yes.
Great. Any other kind of seasonality to pay attention to for the rest of the year, for example, with Medicare Part D redesign and the gross to net fluctuations?
Our gross to net, I think the best way of saying it, it's going to be the most stable that we've ever seen ever. Part of that is just the introduction of the IRA. I think what was different this year is that typically the donut hole, the patients' experiences between that third and fourth quarter time period, here it was the first quarter. You had patients that didn't understand the IRA. You had Medicare providers that didn't understand the IRA. You had a new president that had some rhetoric out there as it related to, should I shut Medicare down? There was a lot of things that occurred. Most patients are through that $2,000 donut hole already. What's really, I guess, cool about that is we see now patients don't have a copay for Nexlizet or Nexletol in Medicare if they're through that.
It is a nice tailwind for us. I think that is really going to help us throughout the year. To emphasize, our GTN is stable and nothing that will be no seasonality that will create any type of negative dynamics towards our business.
Okay. Got it. I guess looking forward to the next couple of years where you have some other competitors in the LDL lowering space, how do you view those other competitors coming onto the market and how that would affect bempedoic acid?
Yeah. This is a really interesting question, one that could actually take up a separate fireside chat if we had one. I'll try to condense this in just a few minutes. Let me just first say that today, physicians can write for Nexlizet or Nexletol. Next year, in 2026, they can continue writing for it with no competition. In 2027, they can write with it with no competition. It's not really until 2028 where you may start seeing competition with drugs like New Amsterdam, oral PCSK9, et cetera. Let me first start with New Amsterdam. First of all, I think all new medications are welcome. This is an environment where cardiovascular disease is the number one killer in the world. We've said that before. With these new assets, there's also a couple of questions we have to address.
As we know, there have been four other CETPs beforehand, and none of them have really ever made it. It was not until about two or three weeks ago that we have actually seen the literature around New Amsterdam and obicetrapib. And I am just quoting the literature. What we hear about is this possible residual risk reduction, this possible effect on Lp(a), and most lately, Alzheimer's, which I think Dennis wrote a note on. Personally, I believe that is a stretch, but let us just focus on lipids. So lipids alone, if you take a look at the data that was produced, for Broadway, if you take a look at the MACE4, and they are still deciding between MACE4 and MACE3, there are 2.6 events in the obicetrapib group and 2.6% events in the placebo group. No difference. If you look at MACE3, there was only a difference in revascularization.
There's no difference in fatal or non-fatal MI. Revascularization is a very soft endpoint. As you know, the data that was shown previously crossed a confidence interval of one. If you are to then say, maybe it's an effect of Lp(a), as we know, the horizon data has been extended because not enough events have occurred until 2026. Let's take a look at the ODYSSEY study and the FOURIER study. If you look at the CTT analysis for both of those, LDL reduction predicted what the residual risk reduction would be, 15%. Both those drugs actually lower Lp(a) at a very similar rate between 13 mg/dl-15 mg/dl . Neither of those studies showed an effect of Lp(a). The point being is you have to have far greater Lp(a) reduction to actually potentially show a result. How big is that? We don't really know.
There have been some studies. I think we have to wait and see what the horizon data shows. I think the other elephant in the room, we've already talked about one, but bringing the other one is that you have an HDL increase of 160 mg/dl . There's this thought out there that LDL is bad cholesterol. That's true. HDL is good cholesterol. We're not sure about that. There's been recent and not so recent publications regarding HDL raising and how much HDL raising is actually harmful and can cause CV events. That's a question that remains to be seen. None of these will be answered until we actually see the outcomes results, which will be sometime in late 2026 or 2027. I think for the oral PCSK9 with Merck, there's an issue with fasting for eight hours.
I think that's going to be really hard for patients to do that. We just don't know enough about the AstraZeneca PCSK9 at this point. That's my take. In the meantime, we have to focus on the drugs that are available today that can save lives. That's bempedoic acid. This drug is going to be here today and possibly even a lot longer than 2031 based upon the news that we released in the past few weeks as early as yesterday.
Okay. So key takeaway, bempedoic acid is approved and completely de-risked, and that should be the focus in terms of commercialization. You speak of IP. Yeah. Can you recap the end of filer settlements for us and what projected exclusivity looks like?
We've had two filers now out of the nine that have essentially settled at no cost, no money exchanged. They've settled for around the April 2040 timeline. That's two out of the nine. It's given us much more confidence of how far we think we can extend our runway. In the past, we've always publicly said that we're planning for June 2031 as our baseline. We've actually started more strategic planning that would be beyond that 2031. You can imagine just the positive benefit of having anything above 2031. We are continuing to gain more and more confidence as we have these folks come to us and settle. To me, it seems as though there's somewhat of a domino effect happening here. Stay tuned. We'll see what happens over the next weeks and months and years.
The fact that folks have come forward already gives us confidence and also reassures what we've always said. We've always said that we believe our manufacturing patents are very strong. This is a very difficult drug to make. It's a dangerous drug to make. We believe that a lot of the folks that filed are looking at these patents, and they're realizing that now.
What's the timeline for resolution of the rest of the end of filer litigation?
The true litigation was not scheduled to occur until 2027. That does not stop end of filers coming to us. All the discovery is complete. Everyone has their cards on the table. I know what they have. They know what we have. I do not, but our law firm does. Who knows? I mean, you could have people coming to us in the next couple of months and saying, we're willing to settle. We're willing to talk. It really remains to be seen. The fact that two have already done it gives us confidence that there potentially could be more.
Okay. Talk about the triple combo as well and how that also could potentially extend IP even more.
Yeah. The triple combo for Daiichi Sankyo, definitely for them, it could extend their IP anywhere from five to ten years. For us, if we continue to see this cascade of settlement, we're looking beyond 2031 in the United States. This is for something that, just to remind you, is ezetimibe plus bempedoic acid and/or either atorvastatin or rosuvastatin. We'll get the choice of those two statins that physicians can choose from. The benefit there is this has the potential to be the most efficacious LDL-lowering drug on the market. I think the other benefit about this drug, we talk about markers of inflammation. As you know, bempedoic acid reduces HSCRP, a known marker of inflammation. Statins lower HSCRP. There is also that pleiotropic effect that we would get from that combination.
We have found physicians to be very excited about having something like this, a drug of convenience, limits pill burden, and provides overwhelming efficacy. We are on plan for that. We have always put a timeline of somewhere near the end of 2027 for that drug to be available. You think about the dates I gave earlier, that is also around the same dates, either on or before competition enters the market.
Okay. What does the regulatory pathway look like for the triple combo in the U.S.?
We have a meeting coming up, another meeting with the FDA very soon. This is really, it's not a true 505(b)(2) type strategy, but it is something where essentially it's just bioequivalence that needs to be done. No large clinical study needs to be conducted unless you would like to have some additional information in the label. That is something we thought about. Would we ever want to do a quick study of efficacy? That's something that we would think about, have no interference on our timeline. It's something that we talk to our advisors about. We have a lipid advisory board. This is just one of the topics that we talk about as we think about lifecycle management.
Okay. If you just do the bioequivalence study, would the label look just like Nexlizet and Nexletol's label?
The labels, we haven't gone through the thorough draft label, but the label would be essentially what you see today in our labels. There'd be no additional new information to promote.
Okay. I want to talk about BD as well. Given that you have a ton of Otsuka milestones coming in, what is your capacity for BD right now? What is your thinking around it? Are there any specific therapeutic areas that you are looking to invest in?
Yeah. Great question. This is something we've been spending a lot of time on. We talked about this at JP Morgan. Let me just give you a quick update on where we are. We've done a significant landscape analysis to look at assets, whether it be anywhere in cardiometabolic, whether it be lipids, obesity, hypertension, heart failure, anything, as I said, cardiometabolic, even diabetes. There are a lot of companies out there today that have drugs in phase three that are either close to filing, have filed, actually have pseudophytates. Many of these companies only have one compound. Many of these companies only have three, four, ten employees. They do not have the ability or the infrastructure to actually launch the drug. I want to be really clear about something. We've always talked about business development as a way to leverage our infrastructure.
One thing that we've had is companies come to us and say, wow, you have a salesforce. You have medical science liaisons. You have a legal department. You have a compliance department. These are all things that necessitate a successful launch of a drug. What's interesting about the macro environment, and actually Jefferies has actually just put out a note about how really biotech, it's really hard to get funding these days. The one silver lining for us in the macro environment is that these companies can't raise the money to spend $80 million to put a salesforce out there. We have 155 people you can leverage today. This is all about leveraging our infrastructure and coming up with a deal that could be revenue sharing, et cetera. We don't need to own the company, but we can certainly act as a vehicle to launch that drug.
We have capacity amongst our field to do that. Stay tuned. We do not want to rush. We do not want to just go and do a deal with any company or any product. We want to make sure it is the right product. It takes a lot of diligence to do that. I do think we are on the right track. Whether that happens at the end of this year or sometime in the beginning of next year, I can assure you it will be something where it is the right product. It just adds more cash to our business as well.
Okay. Just to recap, it sounds like cardiometabolic, something that's really aligned to bempedoic acid, not necessarily a full buyout of the asset. Maybe some sort of co-commercialization agreement could be possible in the next 12 months or so. That's fair?
Yeah, that's fair. It's really something where there's no layout of cash from us. It's more of us lending our infrastructure and helping somebody. We have $114 million in cash. We know that. We can't go out and buy something. We need that money to run our business. This is, to me, is just something where, again, leveraging our infrastructure, helping another company, and also us really getting money for it.
Are you looking mostly in the public markets or also diving into more of the private companies as well?
We are looking at companies that are both public and private.
Okay. With that being said, of not using so much cash, the Otsuka milestones would be more to pay down debt and less so to be used in BD?
Yeah. The Otsuka milestones, obviously, we have a $55 million or $50 million stub that's due in November. The milestones will be used to do that. The milestones would not be, that's not in our mindset right now. We don't have those milestones, and we're thinking about doing the BD today or, like I said, later in the year, early next year. It hasn't come into play that that's what we'd be using the milestones for.
Okay. Got it. In terms of cardiometabolic, can you be a little bit more specific in terms of what within that space you're looking for? Is it really very closely aligned like lipids or more cardiology, say, AFib, something in that area?
I'm not going to talk about the companies specifically. I know you guys have put out notes regarding the companies you think it could be.
I tried.
Yes. You're not far off, okay? It could be more than that. It's really about a high call point overlap. We're calling on cardiologists. Cardiologists treat arrhythmia. They treat heart failure. They treat lipids. Primary care physicians treat arrhythmias. Primary care physicians treat frequent flyers of heart failure. We want something that's a high point overlap. Many of our representatives have deep experience in cardiovascular medicine, so over and beyond just lipids and even extending into liver. I think we can be really flexible. Again, we're also one of the few companies that actually has a primary care salesforce. I think that's very interesting for some of the organizations that potentially would want to partner with us.
Okay. You bring up liver, so the internal pipeline. What are the upcoming updates we can expect from there?
Yeah. On April 24th, we did, not too far down the street, a very successful R&D day where we premiered ESP-1336, a drug for Primary Sclerosing Cholangitis. We feel that in all the drugs in development, we have really the one drug that can really halt the disease. We'll probably hear more about the drug. We'll update you more in the fourth quarter. What I can tell you is that R&D day generated a lot of interest for us. That's more of a, I guess, reverse business development, companies reaching into us. We have BIO in Boston in about two weeks. We have a very full schedule of companies that want to talk about our pipeline and our ACLY biology science. These are both mid-size and big companies. It's an exciting time for us.
I've always said, and it's hard to get credit in biotech for pipeline drugs. Nonetheless, the fact that we're commercializing a drug, the fact that we can actually do research and development and bring a candidate forward is a big deal. It's valuable to us. Other companies now are interested in the science. That was the plan. Us ourselves, we'll update you later in the fall of where we are as we march to IND with this.
What other indications are you exploring in your internal pipeline? Can we expect updates from there as well?
Yeah. Right now, we're focusing on PSC. There are other indications from a liver perspective. I think also what's really interesting is we have an entire kidney program, which we have not even talked about, which we will probably sometime next year. One area that we do not have expertise in, but we have seen signals, is in oncology. Glioblastoma is one area. That's very, very early. We're not the experts there. We do have a very specific scientific advisory board where we have oncologists, we have lipidologists, endocrinologists, et cetera, that can help us think about that and how do we move that forward. The priority right now is really focusing on PSC and obviously our kidney program, which is expansive.
You bring up external interest in these programs. Is the idea for you to fully develop it alone moving forward or to out-license them?
We have always said in our prepared remarks that we believe the pipeline really makes us an interesting candidate for partnerships. I think if we could develop a partnership, we could develop the drug much more quickly. If not, we are prepared to develop it on our own. I do think there is an opportunity for partnerships to help us. We are seeing some initial interest. We will see exactly where that goes.
Okay. Thank you very much, Sheldon. Thank you for being here. Thank you, everyone, for joining us.
Thank you, everyone.